ID

33084

Descripción

Study ID: 104020 Clinical Study ID: 104020 Study Title: Blinded, randomised study to assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ live attenuated measles-mumps-rubella-varicella candidate vaccine when given to healthy children in their second year of life Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00126997 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Combined Measles, Mumps, Rubella, Varicella Vaccine Trade Name: Priorix Tetra Study Indication: Measles; Mumps; Rubella; Varicella

Palabras clave

Versiones (1)
  1. 26/11/18 26/11/18 -
Titular de derechos de autor

GSK group of companies

Subido en

26 de noviembre de 2018

DOI

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Licencia

Creative Commons BY-NC 3.0
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Immunogenicity of Combined Measles, Mumps, Rubella, Varicella Vaccine for healthy 2 y.o children - 104020

Inglés

Study Conclusion Form

1 formularios  
  1. StudyEvent: ODM
    1. Study Conclusion Form
Administrative data
Descripción

Administrative data

Subject Number
Descripción

Subject Number

Tipo de datos

integer

Occurrence of Serious Adverse Event
Descripción

Occurrence of Serious Adverse Event

Did the subject experience any Serious Adverse Events during the study period?
Descripción

Did the subject experience any Serious Adverse Events during the study period?

Tipo de datos

boolean

If Yes, please specify total number of SAE's
Descripción

If Yes, please specify total number of SAE's

Tipo de datos

integer

Status of treatment blind
Descripción

Status of treatment blind

Was the treatment blind broken during this study?
Descripción

For the control group, please tick 'No'

Tipo de datos

boolean

If Yes, please complete date
Descripción

If Yes, please complete date

Tipo de datos

date

Check the reason of blind breach
Descripción

Check the reason of blind breach

Tipo de datos

integer

If Other, specify
Descripción

complete Non-Serious Adverse Event section or Serious Adverse Event form as appropriate

Tipo de datos

text

Elimination Criteria
Descripción

Elimination Criteria

Did any elimination criteria become applicable during the study?
Descripción

Did any elimination criteria become applicable during the study?

Tipo de datos

boolean

If Yes, specify
Descripción

If Yes, specify

Tipo de datos

text

Was the subject withdrawn from study?
Descripción

Was the subject withdrawn from study?

Tipo de datos

boolean

If Yes, please tick the ONE most appropriate category for withdrawal
Descripción

If Yes, please tick the ONE most appropriate category for withdrawal

Tipo de datos

text

If SAE, please specify SAE Number
Descripción

If SAE, please specify SAE Number

Tipo de datos

integer

If Non-SAE please specify unsolicited AE Number
Descripción

If Non-SAE please specify unsolicited AE Number

Tipo de datos

integer

If Protocol violation, please specify
Descripción

If Protocol violation, please specify

Tipo de datos

text

If Other, please specify
Descripción

If Other, please specify

Tipo de datos

text

Please tick who took decision
Descripción

Please tick who took decision

Tipo de datos

text

Date of last contact
Descripción

Date of last contact

Tipo de datos

date

Was the subject in good condition at date of last contact?
Descripción

Was the subject in good condition at date of last contact?

Tipo de datos

text

Investigator's Signature
Descripción

Investigator's Signature

I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my collegues is, to the best of my knowledge, complete and accurate, as of the date below.
Descripción

I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my collegues is, to the best of my knowledge, complete and accurate, as of the date below.

Tipo de datos

date

Investigator's signature
Descripción

Investigator's signature

Tipo de datos

text

Printed Investigator's name
Descripción

Printed Investigator's name

Tipo de datos

text

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Similar models

Study Conclusion Form

1 formularios
  1. StudyEvent: ODM
    1. Study Conclusion Form
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative data
Subject Number
Item
Subject Number
integer
Item Group
Occurrence of Serious Adverse Event
Did the subject experience any Serious Adverse Events during the study period?
Item
Did the subject experience any Serious Adverse Events during the study period?
boolean
If Yes, please specify total number of SAE's
Item
If Yes, please specify total number of SAE's
integer
Item Group
Status of treatment blind
Was the treatment blind broken during this study?
Item
Was the treatment blind broken during this study?
boolean
If Yes, please complete date
Item
If Yes, please complete date
date
Item
Check the reason of blind breach
integer
Check the reason of blind breach
Code List
Check the reason of blind breach
CL Item
Medical emergency requiring identification of investigational product for further treatments (1)
CL Item
Other (2)
If Other, specify
Item
If Other, specify
text
Item Group
Elimination Criteria
Did any elimination criteria become applicable during the study?
Item
Did any elimination criteria become applicable during the study?
boolean
If Yes, specify
Item
If Yes, specify
text
Was the subject withdrawn from study?
Item
Was the subject withdrawn from study?
boolean
Item
If Yes, please tick the ONE most appropriate category for withdrawal
text
If Yes, please tick the ONE most appropriate category for withdrawal
Code List
If Yes, please tick the ONE most appropriate category for withdrawal
CL Item
Serious adverse event (check SAE number) (1)
CL Item
Non-Serious adverse events (check the Non-SAE) (2)
CL Item
Protocol violation (3)
CL Item
Consent withdrawal, not due to an adverse event (4)
CL Item
Migrated/moved from the study area (5)
CL Item
Lost to follow-up (6)
CL Item
Other (7)
If SAE, please specify SAE Number
Item
If SAE, please specify SAE Number
integer
If Non-SAE please specify unsolicited AE Number
Item
If Non-SAE please specify unsolicited AE Number
integer
If Protocol violation, please specify
Item
If Protocol violation, please specify
text
If Other, please specify
Item
If Other, please specify
text
Item
Please tick who took decision
text
Please tick who took decision
Code List
Please tick who took decision
CL Item
Investigator (1)
CL Item
Parents/Guardians (2)
Date of last contact
Item
Date of last contact
date
Item
Was the subject in good condition at date of last contact?
text
Was the subject in good condition at date of last contact?
Code List
Was the subject in good condition at date of last contact?
CL Item
Yes (1)
CL Item
No, please give details within the Adverse Events section (2)
Item Group
Investigator's Signature
I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my collegues is, to the best of my knowledge, complete and accurate, as of the date below.
Item
I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my collegues is, to the best of my knowledge, complete and accurate, as of the date below.
date
Investigator's signature
Item
Investigator's signature
text
Printed Investigator's name
Item
Printed Investigator's name
text
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